MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM

Catalog Number 1011487-15

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was the treat a 90% stenosed, moderately tortuous, moderately calcified lesion in the mid subclavian artery.A 4.0 x 15 mm x 135 cm rx herculink elite stent delivery system (sds) was advanced, but could not cross the lesion due to the patient anatomy and the stent dislodged.The sds and stent implant were carefully removed from the patient anatomy on the guide wire.The procedure was aborted.There was no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device and the reported stent dislodgement was confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties of stent dislodgement, failure to advance and subsequent damages appear to be related to circumstances of the procedure.It was reported that the procedure was the treat a lesion in the mid subclavian artery.It should be noted that instructions for use states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries.In this case, the off-label use does not appear to have contributed to the reported failure to advance or stent dislodgment.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7598884
• MDR Text Key: 111448320
• Report Number: 2024168-2018-04458
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1011487-15
• Device Lot Number: 7080961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: COMMAND .014